BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 5852693 · Received August 8, 2016

    Report

    Report Number
    1030489-2016-02289
    Event Type
    Injury
    Date Received
    August 8, 2016
    Date of Event
    July 14, 2016
    Report Date
    August 23, 2016
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 9392510 AND 510K# K094025 IS NOT APPROVED FOR SALE IN US. (B)(4). NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DET ERMINED.

    Additional Manufacturer Narrative · 1

    X-RAY REVIEW RESULTS: L2-3 TLIF AND L4-5 TLIF POST-OP AND INTRA-REVISION FILMS PROVIDED. NO INITIAL POST-OP SCAN TO EVALUATE HARDWARE PROVIDED. THE L2-3 CAGE IS VERY SMALL AND HAS BACKED OUT ENTIRELY. THE L4-5 CAGE IS ALSO UNDERSIZED AND POSTERIOR IN THE INTERVERTEBRAL SPACE. ROOT CAUSE: SURGICAL TECHNIQUE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTER-BODY FUSION DUE TO LUMBAR SPINAL CANAL STENOSIS AT L3/4.ON AN UNKNOWN DATE POST-OP, PATIENT COMPLAINED OF PAIN AND NUMBNESS OF THE RIGHT LEG DUE TO NERVE COMPRESSION. POSTOPERATIVE, THE PLACED CAGE HAD COMPLETELY BACKED OUT TO THE SPINAL CORD. PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE BACKED OUT CAGE AND AUTOGRAFTING. NEUROLOGICAL SYMPTOMS DUE TO BACKED OUT CAGE WAS REPORTED. REPORTEDLY, AFTER REVISION SURGERY, THE PATIENT SAID THE PAIN IS GETTING BETTER AFTER HE WOKE UP FROM ANESTHESIA. THE WAVEFORM WAS CONFIRMED BY MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507521 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 41AN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention